Tweet
If and when this bill is signed into law, it becomes law within 10 days. I've read an article that they won't be able to implement all of the changes right away, because the budget for 2016 has already been decided. However, different trial designs, fda review process, or use of biomarkers isn't something that should cost money, since it's more of a policy change.
It is my opinion that we could see Seti in a year. This drug has had 8 clinical trials, thousands of patients with strong safety data, and even made it through a phase 3. Technically, it has made it through trials, but they want to test it for a different application, and using the same method (oral medication). I've read all of the literature on the proposed changes, and Setipiprant strikes me as an excellent example of a drug that could really be accelerated under the new laws.
There is a proposed change to the law that would allow drugs that are repurposed to hit the market without trials, but with more strict feedback and market review once it's hit the market. I think a drug like Setipiprant *could* be released once the law is signed without going through at least 1 trial, because it has gone through 8 trials, and a phase 3 (which technically means passing the FDA rules), but I doubt it.
The provision for use of biomarkers could also really speed things up, because they could easily answer the question - does setipiprant reduce pgd2 levels to normal in the scalp? They could test that with technical equipment, rather than having participants take the drug for 6 months. There has been some controversy over biomarkers with regards to treating cancer, and does a particular drug actually treat the cancer, as opposed to just shrinking a tumor etc etc. BUT this is hair loss. Excess PGD2 in the scalp or not, we are all otherwise healthy.
It is my opinion that we could see Seti in a year. This drug has had 8 clinical trials, thousands of patients with strong safety data, and even made it through a phase 3. Technically, it has made it through trials, but they want to test it for a different application, and using the same method (oral medication). I've read all of the literature on the proposed changes, and Setipiprant strikes me as an excellent example of a drug that could really be accelerated under the new laws.
There is a proposed change to the law that would allow drugs that are repurposed to hit the market without trials, but with more strict feedback and market review once it's hit the market. I think a drug like Setipiprant *could* be released once the law is signed without going through at least 1 trial, because it has gone through 8 trials, and a phase 3 (which technically means passing the FDA rules), but I doubt it.
The provision for use of biomarkers could also really speed things up, because they could easily answer the question - does setipiprant reduce pgd2 levels to normal in the scalp? They could test that with technical equipment, rather than having participants take the drug for 6 months. There has been some controversy over biomarkers with regards to treating cancer, and does a particular drug actually treat the cancer, as opposed to just shrinking a tumor etc etc. BUT this is hair loss. Excess PGD2 in the scalp or not, we are all otherwise healthy.
Comment